Sr. Design Transfer Engineer

If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process.

Full-Time Professional Eden Prairie, MN, US

4 days ago Requisition

Salary Range: $ To $ Annually

Annual CIP bonus opportunity of up to $13,000.00

• Serves as a lead core team member of a cross functional project team whose responsibilities include conducting studies directed toward the development of processes
• Performs standard scientific assignments to evaluate results for validity and conformance to acceptable scientific methods. Independently determines requirements and acceptance criterion associated with testing performed.
• Applies deep knowledge of six sigma methodologies (process capability, SPC, etc.) to assess product design and translate them into process specifications
• Participates and consults with the internal and external scientific community to maintain a state-of-the-art knowledge for application to achieving successful experimental outcomes
• Deploys deep knowledge of manufacturing to suggest and implement creative solutions in process development and test method creation innovating manual hand driven processes to semi-automated equipment driven processes.
• Coordinates or performs validations and documents risk management activities to support regulatory submissions or product launches
• Leverages expertise across projects and specialties to effectively accomplish assignments and identify and mitigate risks within a project.
• Leverages clinical and technical expertise to evaluate design and process risks and implement effective mitigation measures
• Exhibits functional autonomy through creating project direction assigning design transfer deliverables required to support both new product development projects and design change projects
• Reviews and edits internal documentation for team members and assists in the preparation and presentation of materials for internal or external technical reviews
• May serve as a team lead and have direct reports
• Supports Quality process improvement initiatives

• Bachelor’s degree in relevant area

• 6+ years of relevant medical device, pharmaceutical, or other regulated industry experience

N/A

• Strong attention to detail and documentation practices
• Ability to work independently in a small-company environment
• Effective communication and cross-functional collaboration
• Problem-solving and investigative mindset
  
  Strong knowledge of microbiological techniques and aseptic processing

N/A

• Move or lift objects up to 25 pounds
• Frequent (>75%) stationary position (standing or sitting) while utilizing digital displays
• Frequent (>75%) fine manipulation using hands and fingers (typing, opening, writing, clicking, paper sorting, etc.)
• Onsite:
  Office environment with assigned workstation
• Remote positions only:
  Home office environment with minimum distractions